Book Details

Hardcover: 1248 pages
Publisher: Wiley; 1 edition (July 7, 2009)
Language: English
ISBN-10: 0471213888
ISBN-13: 978-0471213888.

Book Description

Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials.

With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including:

• Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems)
• Biostatistics, pharmacology, and toxicology
• Modeling and simulation
• Regulatory monitoring and ethics
• Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more

With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

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Book Details

Paperback: 256 pages
Publisher: Oxford University Press, USA; 1 edition (March 29, 2007)
Language: English
ISBN-10: 019852997X
ISBN-13: 978-0198529972.

Book Description

It is increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, for example drugs, devices or diagnostics; aid companies seeking to make claims about the cost-effectiveness of their product; allow early consideration of the economic value of therapies, which may be important to improving initial adoption decisions; or address the requirements of regulatory bodies. Economic Evaluation in Clinical Trials uses a consistent set of data collected within the trial, or by projection from this data, and avoids having to incorporate unrelated (and potentially inconsistent) data from many different sources.

This book provides a practical guide to conducting economic evaluation in ongoing clinical trials. It covers issues and techniques related to the collection of both cost and outcome data, as well as a framework for reporting and interpreting economic reports from clinical trials. This is illustrated by detailed supporting examples and exercises, designed to teach the reader how to apply this model. These exercises are supported with datasets, programmes and solutions made available online.

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Book Details

Format: Kindle Edition
Print Length: 289 pages
Publisher: Springer; 1 edition (December 15, 2006)
Language: English
ASIN: B001BUYADQ.

Book Description

There is a lack of treatises dealing with investigative electrocardiographic research. Investigative Electrocardiography in Epidemiological Studies and Clinical Trials provides background information on procedures, epidemiological aspects, problem areas, mortality and morbidity risk. These topics are of particular interest for investigators in ECG research and clinical trials. This monograph is specialized beyond the scope of ordinary clinical textbooks of electrocardiography that have traditionally flooded the market.

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Book Details

Format: Kindle Edition
Print Length: 208 pages
Publisher: Wiley; 1 edition (September 9, 2002)
Language: English
ASIN: B000PY456G.

Book Description

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.

• Provides a practical overview of data monitoring in clinical trials.
• Describes the purpose, responsibilities and operation of data monitoring committees.
• Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
• Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
• Discusses issues pertinent to those working in clinical trials in both the US and Europe.

The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

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Book Details

Hardcover: 288 pages
Publisher: Wiley-Interscience; 1 edition (July 11, 2002)
Language: English
ISBN-10: 0471236268
ISBN-13: 978-0471236269.

Book Description

A unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications.

The role of randomization techniques in clinical trials has become increasingly important. This comprehensive guide combines both the applied aspects of randomization in clinical trials with a probabilistic treatment of properties of randomization. Taking an unabashedly non-Bayesian and nonparametric approach to inference, the book focuses on the linear rank test under a randomization model, with added discussion on likelihood-based inference as it relates to sufficiency and ancillarity. Developments in stochastic processes and applied probability are also given where appropriate. Intuition is stressed over mathematics, but not without a clear development of the latter in the context of the former.

Providing a consolidated review of the field, the book includes relevant and practical discussions of:
* The benefits of randomization in terms of reduction of bias
* Randomization as a basis for inference
* Covariate-adaptive and response-adaptive randomization
* Current philosophies, controversies, and new developments

With ample problem sets, theoretical exercises, and short computer simulations using SAS, Randomization in Clinical Trials: Theory and Practice is equally useful as a standard textbook in biostatistics graduate programs as well as a reliable reference for biostatisticians in practice.

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Book Details

Hardcover: 288 pages
Publisher: Wiley-Blackwell; 1 edition (July 27, 2009)
Language: English
ISBN-10: 1405179260
ISBN-13: 978-1405179263.

Book Description

* A comprehensive source of information on the management of cardiogenic shock
* Part of the AHA Clinical Series published in conjunction with the American Heart Association
* Focuses on high-interest and emerging topics in cardiovascular disease targeted to cardiologists and other interested healthcare providers
* A useful tool for investigating, evaluating and treating one of the most important lingering challenges in acute cardiovascular care.

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Book Details

Hardcover: 306 pages
Publisher: Wiley-Blackwell; 1 edition (April 15, 2000)
Language: English
ISBN-10: 0632050713
ISBN-13: 978-0632050710.

Book Description

Yonsei University, Seoul, Korea. Provides the dermatologist with a sound base of clinical wisdom and key scientific findings from which to make a diagnosis and management plan. Includes sections on the definition of vitiligo, a complete description of its clinical manifestations, and physiological changes. DNLM: Vitiligo–diagnosis.

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Clinical Trials: Design, Conduct, and Analysis (Monographs in Epidemiology and Biostatistics, Vol

Book Details

Hardcover: 496 pages
Publisher: Oxford University Press, USA; 1 edition (March 27, 1986)
Language: English
ISBN-10: 0195035682
ISBN-13: 978-0195035681.

Book Description

The definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clincal trials offers as much detail as Meinert does on such issues as sample size calculation, stratification and randomization, data systems design, consent form development, publication policies, preparation of funding requests, and reporting procedures.

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Book Details

Spiral-bound: 320 pages
Publisher: Singular; 2 edition (February 1, 2003)
Language: English
ISBN-10: 0769301002
ISBN-13: 978-0769301006.

Book Description

Developmental Reading Disabilities, 2nd Edition provides the perspective that early speech and language problems may contribute to reading problems. The relationship between oral language problems and written language problems is presented followed by tools and models of assessment and treatment. Collaboration between oral and written language specialists is encouraged to help get to the root of the child’s difficulties in these areas. An abundance of resources are provided for the practitioner to aid in his or her work with this population of children.

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Book Details

Paperback: 280 pages
Publisher: Springer Publishing Company; 1 edition (September 26, 2006)
Language: English
ISBN-10: 0826102689
ISBN-13: 978-0826102683.

Book Description

Nursing is a crucial component of our healthcare system, and yet, unlike the services provided by doctors, the care given to patients by our nurses remains largely undocumented in a measurable format. Because of the lack of available data, nursing is rarely considered by the government when changes are made to our healthcare system, and as a consequence nursing continues to suffer the most severe budget cuts and lack of support. All of which greatly affect the care patients receive and damages our overall healthcare system. To address this oversight and counter the growing frustration in the nursing community, Virginia Saba created a PMRI compatible coding system that fully documents the specifics and impact of nursing in a singular terminology. The Clinical Care Classification (CCC) system can be used regardless of health care setting and covers Nursing Diagnoses and Outcomes as well as Nursing Interventions and Action Types. This manual brings together the CCC terminology that was previously only available on Dr. Saba’s website with background on its development and instructions on how best to code and apply the terminology. The CCC is the only system of its kind devoted to streamlining and classifying nursing and its impact in medicine. It is already changing the way nursing is viewed in the medical community and with this manual it is another step closer to bringing nurses the recognition they deserve as integral members of patient care.

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